This is a First-in-Human, Randomized, Placebo-controlled, Single Ascending Oral Dose Study of SDI-118 in Healthy Male Subjects including Receptor Occupancy Measurements after Single Dose of SDI-118 and an Assessment of Food Effect.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
32
Centre for Clinical Pharmacology, UZ Leuven
Leuven, Belgium
Number of participants with Adverse Events (AEs)
Adverse events (AEs) will be coded using medical dictionary for regulatory activities (MedDRA). An AE is any untoward medical occurrence in a participant administered a study drug and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medical product whether or not considered related to the medical product. An AE is considered "serious" if, in the view of either the investigator or sponsor, the event: results in death, is life-threatening, results in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, results in congenital anomaly or birth defect, requires hospitalization or prolongation to hospitalization, or other medically important event.
Time frame: 21 Days
Number of participants with laboratory value abnormalities and/or adverse events (AEs)
Number of participants with potentially clinically significant laboratory values (hematology/chemistry/urinalysis)
Time frame: 21 Days
Number of participants with vital sign abnormalities and/or adverse events (AEs)
Number of participants with potentially clinically significant vital sign values
Time frame: 21 Days
Number of participants with temperature abnormalities and/or adverse events (AEs)
Number of participants with potentially clinically significant temperature values
Time frame: 21 Days
Number of participants with routine 12 lead electrocardiogram (ECG) abnormalities and/or Adverse Events (AEs)
Number of participants with potentially clinically significant ECG values.
Time frame: 21 Days
Number of participants with routine physical examination abnormalities and/or Adverse Events (AEs)
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Number of participants with potentially clinically significant changes in physical examination.
Time frame: 21 Days
Number of participants with routine neurological examination abnormalities and/or Adverse Events (AEs)
Number of participants with potentially clinically significant changes in neurological examination.
Time frame: 21 Days
Number of participants with abnormalities on Profile of Mood States (Brief) and/or Adverse Events (AEs)
Number of participants with potentially clinically significant changes in Profile of Mood States (Brief) values.
Time frame: 21 Days
Number of participants with abnormalities on Bond-Lader-VAS and/or Adverse Events (AEs)
Number of participants with potentially clinically significant changes in Bond-Lader VAS values.
Time frame: 21 Days